Profile: Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps tri-gem microscope utilizes a quartz-halogen fiberoptic illumination system. The source is mounted on the microscope arm allowing the fiberoptic cable to be shorter. This combination enables the maximum of light to be transmitted to the field.

The company has revenues of < USD 1 Million, has ~40 employees and is ISO certified.

FDA Registration Number: 1926681

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• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Rhodium Mirrors

• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Routine Fiberoptic Light Source (FDA Code: FCW / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Russian Pattern Tissue Forceps

• Russian Tissue Forceps

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Sclera Marker (FDA Code: HMQ / 886.4570) An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Sinus Cannula (FDA Code: KAM / 878.4800)

• Sinus Endoscopy, Ear Speculums

• Sinus Endoscopy, Nasal Scissors

• Sinus Endoscopy, Nasal Speculum

• Sinus Irrigator (FDA Code: KAR / 874.4420)

• Sinus Scopes

• Sinus Trocar (FDA Code: KBG / 874.4420)

• Soft Ear Speculum (FDA Code: EPY / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Spectrum Cabinet

• Stainless Steel Cabinet

• Stainless Steel Micro Tissue Forceps

• Stainless Steel Russian Tissue Forceps

• Steam Sterilizers (FDA Code: FLE / 880.6880) A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

• Sterile ENT Cutting Block (FDA Code: JXS / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540)

• Sterilizers

• Stevens Tenotomy Scissors

• Stitch Scissors

• Straight Tissue Forceps

• Strobovideolaryngoscopy System

• Suction Catheter and Tip (FDA Code: JOL / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Suction Irrigator

• Suction Tubes

• Surgical Aspirator

• Surgical Aspirator Tips

• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Surgical Cochlear Implant (FDA Code: MCM)

• Surgical Headband Light (FDA Code: FSR / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

• Surgical Microscope 3CCD Cameras

• Surgical microscope for ENT Surgeons, Ophthalmic Surgeons

• Surgical microscope for Gynecologist Surgeons

• Surgical Microscope Light Sources

• Surgical Microscope Mount

• Surgical Microscope Repair Service

• Surgical Microscope Video Adapters

• Surgical Microscope Video Camera Adapters

• Surgical Microscopes

• Surgical Microscopes (FDA Code: EPT / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

• Surgical Microscopes Loupes